Clinical trials: Valve Heart Disease
Tricuspid Regurgitation, Tricuspid Insufficiency
Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)
The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.
- Trial name
- TriBAND (NCT03779490)
- Testing
- Transcatheter Tricuspid Valve Repair
- Where
- 14 sites in Germany, Spain and 1 more
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Transfemoral Implant of Inovare® Transcatheter Valve
Clinical trial to evaluate the early safety and efficacy of the transfemoral implant of Inovare® Transcatheter Valve for the treatment of patients with severe degenerative aortic stenosis and high surgical risk.
- Trial name
- NCT05531578
- Testing
- INOVARE® Transcatheter Valve, NexusCath Delivery System, Aureus Expandable Introducer, Balloon Catheter for Pre-Dilation and Compression Device (Crimper)
- Where
- 4 sites in Brazil
- Volunteers
- 60 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Aortic Valve Stenosis
Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following TAVI Procedure
This study is designed to monitor the safety and performance of the V8 balloon when used as a postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI) device procedures.
- Trial name
- PostCorE (NCT02472106)
- Testing
- Post-dilatation
- Volunteers
- 9 people
- Sponsor
- InterValve, Inc.
Aortic Stenosis Symptomatic
Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis
A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medical
- Trial name
- NCT06721676
- Testing
- transcatheter aortic valve replacement in severe aortic stenosis
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Mitral Regurgitation, Mitral Insufficiency
5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
Single-center clinical investigation is to evaluate long-term safety and performance of the Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV) surgery using Medtentia's MAR system in…
- Trial name
- NCT04161079
- Testing
- Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy
Severe, Symptomatic
The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.
- Conditions
- Severe, Symptomatic, Calcific Aortic Stenosis
- Trial name
- PARTNERII B (NCT02184442)
- Testing
- TAVR Implantation with SAPIEN XT, TAVR Implantation with SAPIEN
- Where
- 53 sites in United States
- Volunteers
- 560 people
- Sponsor
- Edwards Lifesciences
Myocardial Infarction, Percutaneous Transluminal Coronary Angioplasty
Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence
The aim of this study is to evaluate feasibility, efficacy, and adherence of home-based cardiac rehabilitation with the integration of telemedicine.
- Conditions
- Myocardial Infarction, Percutaneous Transluminal Coronary Angioplasty, Coronary Artery Bypass, Stable Angina
- Trial name
- NCT05972070
- Testing
- ROMTech Portable Connect
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- ROM Technologies, INC
Mitral Regurgitation, Mitral Valve Disease
Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting.
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Insufficiency, Mitral Valve Prolapse
- Trial name
- AcChord (NCT04190602)
- Testing
- NeoChord Artificial Chordae Delivery System, Model DS1000
- Where
- 5 sites in Germany, Greece and 1 more
- Volunteers
- 500 people
- Sponsor
- NeoChord
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow…
- Conditions
- Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease
- Trial name
- NCT03130777
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
- Where
- 14 sites in United States
- Volunteers
- 86 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
VitaFlow LIBERTY Europe
This is a prospective, single-arm, multi-center, observational, post-market clinical investigation to document the clinical safety and performance of MicroPort CardioFlow VitaFlow Liberty™ Transcatheter Aortic Valve System in the…
- Trial name
- NCT06535659
- Testing
- VitaFlow Liberty™ Transcatheter Aortic Valve System
- Where
- 9 sites in Ireland, Italy and 3 more
- Volunteers
- 222 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Heart Valve Diseases, Aortic Valve Stenosis
BIOVALVE - I / II Clincial Investigation
First-in-Human clinical investigation to evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team…
- Trial name
- BIOVALVE (NCT02249000)
- Testing
- BIOVALVE prosthesis
- Where
- 13 sites in Belgium, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- Biotronik AG
Mitral Valve Insufficiency, Heart Failure
Carillon Mitral Contour System® for Reducing Functional Mitral Regurgitation
The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart…
- Trial name
- REDUCE FMR (NCT02325830)
- Testing
- Carillon Mitral Contour System
- Where
- 31 sites in Australia, Czechia and 6 more
- Volunteers
- 163 people
- Sponsor
- Cardiac Dimensions Pty Ltd
Obstructive Hypertrophic Cardiomyopathy, Healthy Adult Subjects
Safety, Tolerability and Pharmacokinetics Study of CK-3773274
The purposes of this study are to: 1. Learn about the safety of CK-3773274 after a single dose and multiple doses in Chinese healthy adult subjects. 2.
- Trial name
- NCT04783766
- Testing
- CK-3773274
- Where
- China
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Corxel Pharmaceuticals
Aortic Stenosis
ACURATE TA™ Valve Implantation Registry: SAVI 2
Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to collect continued surveillance data pertaining to…
- Trial name
- TA-SAVI2 (NCT02663375)
- Testing
- ACURATE TA™ Transapical Aortic Bioprosthesis
- Where
- 27 sites in Austria, Germany and 2 more
- Volunteers
- 250 people
- Sponsor
- Symetis SA
Tricuspid Valve Regurgitation
Clinical Study of the inQB8 TTVR System (The MonarQ Study)
Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.
- Trial name
- NCT06611579
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 8 sites in United States, Belgium and 1 more
- Volunteers
- 50 people
- Sponsor
- inQB8 Medical Technologies, LLC
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Trifecta™ Long Term Follow-Up (LTFU) Study
The Trifecta™ LTFU Study is a single-arm, multi-center, prospective, non-randomized, post-market study conducted in the United States and Canada to collect long-term safety and effectiveness data through 10 years after implant of…
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT01593917
- Testing
- Trifecta™ Valve
- Where
- 11 sites in United States, Canada
- Volunteers
- 329 people
- Sponsor
- Abbott Medical Devices
Parkinson's Disease, Hyperprolactinemia
The Association Between Dopamine Agonists and Cardiac Valvulopathy, Fibrosis and Other Cardiopulmonary Events
To assess the association between cabergoline and other dopamine agonists (DAs), and symptomatic, diagnosed serious cardiopulmonary disorders, including: 1. Cardiac valve regurgitation 2.
- Trial name
- NCT01052948
- Testing
- Retrospective study-
- Volunteers
- 86,939 people
- Sponsor
- Pfizer
Mitral Valve Prolapse
St. Jude Medical Percutaneous Mitral Valve Repair Study
The purpose of this proof-of-concept study is to assess the relative safety and feasibility of the SJM Percutaneous Mitral Valve Repair (PMVr) Device.
- Trial name
- SJM PMVr (NCT01500148)
- Testing
- PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)
- Where
- United Kingdom
- Volunteers
- 2 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Regurgitation
Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study
Evaluation of the technical feasibility and safety of the Mitral Adjustable Annuloplasty Ring.
- Trial name
- MAARS (NCT00554151)
- Testing
- Adjustable Annuloplasty Ring
- Where
- 5 sites in Germany, Italy and 1 more
- Volunteers
- 55 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis, Aortic Regurgitation
Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease
To compare changes in Left Ventricular Mass (LVM) depending on each blood pressure regulation between the intensive care group and the usual care group for patients with hypertension accompanied by aortic valve disease and…
- Conditions
- Aortic Stenosis, Aortic Regurgitation, Hypertension, LVM
- Trial name
- NCT03666351
- Testing
- Amlodipine 5mg, Losartan, Losartan and Amlodipine
- Where
- South Korea
- Volunteers
- 128 people
- Sponsor
- Hanmi Pharmaceutical Company Limited